Anesthesia and Cancer Study: Colon Cancer
Primary Purpose
Cancer of Colon, Anesthesia
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Propofol
Sevoflurane
Sponsored by
About this trial
This is an interventional prevention trial for Cancer of Colon focused on measuring anesthesia, propofol, cancer, inhalational anesthetics
Eligibility Criteria
Inclusion Criteria:
- adults undergoing surgery to remove colon cancer
Exclusion Criteria:
- pregnancy
- colon cancer with invasion to perineum
- palliative surgery
- history of diagnosis or surgery for other cancer
- emergent surgery
- ASA PS classification 4 and 5
- refusion to participate in the study
- allergy to anesthetics
Sites / Locations
- Seoul Metropolitan Government Seoul National University Boramae Medical CenterRecruiting
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TIVA
inhalation (Sevoflurane)
Arm Description
propofol infusion targeting bispectral index 40-60
sevoflurane targeting bispectral index 40-60
Outcomes
Primary Outcome Measures
five year survival
survival rate regardless of recurrence
Secondary Outcome Measures
five year recurrence free survival
survival rate without recurrence
1 year recurrence free survival
survival rate without recurrence
3 year recurrence free survival
survival rate without recurrence
1 year survival
survival regardless of recurrence
3 year survival
survival regardless of recurrence
Full Information
NCT ID
NCT04259398
First Posted
February 4, 2020
Last Updated
May 3, 2022
Sponsor
Seoul National University Hospital
Collaborators
Korean Society of Anesthesiologists, Bundang Seoul National University Hospital, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Seoul St. Mary's Hospital, Seoul National University Boramae Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04259398
Brief Title
Anesthesia and Cancer Study: Colon Cancer
Official Title
The Influence of Type of Anesthesia on Mortality and Cancer Recurrence After Colon Cancer Surgery: Multi-center Prospective Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 18, 2020 (Actual)
Primary Completion Date
February 1, 2026 (Anticipated)
Study Completion Date
February 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Korean Society of Anesthesiologists, Bundang Seoul National University Hospital, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Seoul St. Mary's Hospital, Seoul National University Boramae Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
This study investigates the influence of type of anesthesia on survival and recurrence rate in patients receiving colon cancer surgery. The participants will be allocated to either the TIVA group and the inhalation group.
Detailed Description
The effect of anesthesia on cancer recurrence and survival is controversial. According to some retrospective studies and preclinical studies, total intravenous anesthesia (TIVA) is suggested to be more favorable than inhalation anesthesia regarding cancer recurrence and survival after surgery. However, there is no randomized controlled study to determine this difference in colon cancer patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Colon, Anesthesia
Keywords
anesthesia, propofol, cancer, inhalational anesthetics
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
792 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TIVA
Arm Type
Experimental
Arm Description
propofol infusion targeting bispectral index 40-60
Arm Title
inhalation (Sevoflurane)
Arm Type
Active Comparator
Arm Description
sevoflurane targeting bispectral index 40-60
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
propofol 1-2 mg/kg bolus injection for induction of anesthesia propofol continuous infusion for maintenance of anesthesia
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
sevoflurane is administered for induction and maintenance of anesthesia
Primary Outcome Measure Information:
Title
five year survival
Description
survival rate regardless of recurrence
Time Frame
five years survival
Secondary Outcome Measure Information:
Title
five year recurrence free survival
Description
survival rate without recurrence
Time Frame
five years after surgery
Title
1 year recurrence free survival
Description
survival rate without recurrence
Time Frame
1 year after surgery
Title
3 year recurrence free survival
Description
survival rate without recurrence
Time Frame
3 years after surgery
Title
1 year survival
Description
survival regardless of recurrence
Time Frame
1 year after surgery
Title
3 year survival
Description
survival regardless of recurrence
Time Frame
3 years after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adults undergoing surgery to remove colon cancer
Exclusion Criteria:
pregnancy
colon cancer with invasion to perineum
palliative surgery
history of diagnosis or surgery for other cancer
emergent surgery
ASA PS classification 4 and 5
refusion to participate in the study
allergy to anesthetics
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin-Tae Kim
Phone
+821062608490
Email
jintae73@gmail.com
Facility Information:
Facility Name
Seoul Metropolitan Government Seoul National University Boramae Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae Kyung Kim, Pf.
Phone
82-2-870-3020
Email
ktkktk@gmail.com
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Tae Kim, Pf.
Phone
+82-2-2072-3295
Email
jintae73@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Anesthesia and Cancer Study: Colon Cancer
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